Operations in China, Hong Kong, Taiwan, South Korea and USA,
Highquality performanceat competitive prices.
A senior management team with decades of experience working with the world’s leading pharmaceutical companies and CROs.
Effective and transparent communication.
One-stop services covering a full range of regulatory and clinical trial supports.
7 days/24 hours non-stop technical support servicesin Data Management and Biostatistics.
Global quality guaranteed by SOPs compatible with ICH-GCP.
1. Fountain provides access to the largest patient populations. We have access to more than 300 GCP Centers and more than1000 investigators in China. We are also connected with clinical research centers, hospitals and principal investigators in Hong Kong, Taiwan and South Korea.
2. Fountain is the only full service CRO regionally based in Asia that is experienced in delivering global quality data and supporting submissions in the US, EU and Japan.
3. Our clinical study data management operation spans both US and China. With more than 14 years of experience working with the USFDA drug registration system, FMD has an established record of high quality data management that meets rigorous international standards. FMD can provide MediData Rave, Oracle Clinical RDC, Oracle Inform and Open Clinica. What’s more, FMD is a Gold member of CDISC. With such system is place, we can provide our clients with professional data and statistical analysis.
4. At Fountain, safety matters! Our full pharmacovigilance service minimizes risks and ensures a high level of confidence in your product. Fountain operates the first and so far the only DSMB (Data Safe Monitoring Board) in China to guarantee high-quality handling of safety operations.
5. Fountain offers proven strategies and operational excellence. We have provided entry strategies for many pharmaceutical, medical device and biotech companies in the US and Europe.
1. FMD CEO Dr. Dan Zhang is the only CDE advisor coming from China’s CRO industry. FMD maintains the most up-to-date regulatory information in hand. And FMD has the most experienced regulatory team handling fast-track/accelerated drug application in China.
2. FMD has a dedicated 10 member regulatory affairs team in Beijing, having successfully handled more than 50 IND/CTA/NDA and regulatory consulting projects over the last 5 years. In addition, FMD has a team of 12 regulatory consultants, including former CFDA employees.
3. FMD has a solid track record of handling difficult regulatory projects.FMD has successfully handled many test cases. In one of the cases, CFDA granted permission for our sponsor to conduct early phase clinical studies in parallel with the international studies, which was then unprecedented.
4. FMD is also experienced in handling IND/NDAs in South Korea, Hong Kong, Taiwan, Singaporeand USA.